Validation of the Foot Health Status Questionnaire in French Language

NCT ID: NCT06933953

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-02-28

Brief Summary

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A French foot health survey showed that 73% of people examined felt pain and 38% don't left their home, which suggest a reduction in their life's quality and autonomy. Developed by Paul Bennett, FHSQ is a foot health-specific self administrated questionnaire. It sensitively detects changes in patients' foot health status, whatever their pathology, across multidimensional concepts of their quality of life. Actually, more than 150 scientific publications have cited it. Reliable and valid, it has already been translated and validated in multiple languages, but not in French. The subject of this study is to validate the translated and cross-cultural adapted French version FHSQ-fr through its psychometric results of validity and reliability. The study follows a 2-stage methodology.

The first, already completed, consisted of (back)translating the Australian FHSQ questionnaire into French by a scientific committee in order to obtain a pre-final version.

The second is to validate this final version using appropriate statistical analysis, including correlations studies with other French validated questionnaires, to determine its psychometric characteristics.

Detailed Description

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To assess validity, 150 volunteers will fill out French validated questionnaires, Foot Function Index (FFI), EuroQuality of life 5D-5L (EQ5D) , Visual Analogic Pain Scale (VAPS), and Short Form 12 Health survey (SF12). They will be evaluated about their pain, morphology, function and posture of their feet as usual at a podiatric school. To assess reliability, 50 respondents from the 150 who didn't receive any treatment after 7 to 10 days, will complete the FHSQ-fr again. It would improve knowledge of the status of foot health and its related quality of life in the general population and those suffering from specific pathologies such as diabetes or rheumatoid arthritis, the effectiveness of certain treatments on the same foot condition, and their evolutions using longitudinal studies in France. At the international, the French future results of studies using this clinimetric tool could be compared with those who come from other countries, and integrated to the Australian author's " Bigdataset" which compares, analyses and predicts more accurately the clinically significant efficacy of a treatment.

Conditions

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Patients With Foot Problems

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with foot problems

Patients will complete many questionnaires : FHSQ-fr, Foot Function Index, EQ-5D-5L, Visual Analog Pain Scale, SF-12

Group Type OTHER

Questionnaires

Intervention Type OTHER

Patients will complete various questionnaires at J0: FHSQ-Fr, EQ-5D-5L, Foot Function Index, Visual analog pain scale, SF-12.

Patients who needs to come back for a visit at Day 7 (+ 3 days) will complete the FHSQ-Fr questionnaire for a second time

Interventions

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Questionnaires

Patients will complete various questionnaires at J0: FHSQ-Fr, EQ-5D-5L, Foot Function Index, Visual analog pain scale, SF-12.

Patients who needs to come back for a visit at Day 7 (+ 3 days) will complete the FHSQ-Fr questionnaire for a second time

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients coming to IFRES in Alençon (61) France for a pedicure or podiatry appointment,
2. Age \>= 18
3. knowing how to speak, read and write French.

Exclusion Criteria

1\. Have already taking part in this research before the proposition to get in.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine GUYET

Role: PRINCIPAL_INVESTIGATOR

IFRES of Alençon

Locations

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Ifres Ecole de Pedicure Podologie

Alençon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphanie MARDHEL

Role: CONTACT

0788586556 ext. +33

Facility Contacts

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Delphine GUYET

Role: primary

0661445164 ext. +33

References

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Burzykowski T, Molenberghs G, Abeck D, Haneke E, Hay R, Katsambas A, Roseeuw D, van de Kerkhof P, van Aelst R, Marynissen G. High prevalence of foot diseases in Europe: results of the Achilles Project. Mycoses. 2003 Dec;46(11-12):496-505. doi: 10.1046/j.0933-7407.2003.00933.x.

Reference Type BACKGROUND
PMID: 14641624 (View on PubMed)

Lopez-Lopez D, Perez-Rios M, Ruano-Ravina A, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Romero-Morales C, Calvo-Lobo C, Navarro-Flores E. Impact of quality of life related to foot problems: a case-control study. Sci Rep. 2021 Jul 15;11(1):14515. doi: 10.1038/s41598-021-93902-5.

Reference Type BACKGROUND
PMID: 34267276 (View on PubMed)

Valensi P, Girod I, Baron F, Moreau-Defarges T, Guillon P. Quality of life and clinical correlates in patients with diabetic foot ulcers. Diabetes Metab. 2005 Jun;31(3 Pt 1):263-71. doi: 10.1016/s1262-3636(07)70193-3.

Reference Type BACKGROUND
PMID: 16142017 (View on PubMed)

Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.

Reference Type BACKGROUND
PMID: 9770933 (View on PubMed)

Related Links

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https://www.sante-du-pied.org/lufsp/les-chiffres/

A few figures on foot health in France - UFSP

Other Identifiers

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CHUO-2024-12

Identifier Type: -

Identifier Source: org_study_id

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